Agennix Receives Orphan Drug Designation for Cancer Treatment
Posted on: Thursday, 12 October 2006, 15:01 CDT
Agennix has said the FDA has granted orphan drug designation to the company's oral formulation of Talactoferrin Alfa for the treatment of renal cell carcinoma.
Oral TLF is currently in phase II clinical development for RCC. Talactoferrin Alfa is a unique recombinant form of human lactoferrin, known as an immunomodulatory protein.
"Metastatic RCC is a devastating disease with limited treatment options," said Dr Teresa Hayes, a Medical Oncologist at the Baylor College of Medicine. "Several of my patients have done extremely well for a very long time on treatment with oral single-agent talactoferrin. The medication is easy to take and has few side effects."
Agennix also recently received FDA fast track designation for the company's clinical development programs for oral TLF solution in first-line non-small cell lung cancer and topical TLF gel in diabetic foot ulcers.
Agennix said it plans to seek FDA approval for a phase III trial in non-small cell lung cancer and plans to start the study next year.
Source: Datamonitor
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